Health agencies in the U.S. called Tuesday for a pause in the use of Johnson & Johnson’s coronavirus vaccine as officials investigate blood clots reported in six individuals who received the vaccine.
In a joint statement early Tuesday, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said they are “recommending a pause in the use of this vaccine out of an abundance of caution.”
Update 12:55 p.m. ET April 13: The White House COVID-19 response coordinator Jeffrey Zients said Tuesday that the decision to pause the administration of Johnson & Johnson’s coronavirus vaccine “will not have a significant impact on our vaccination program.”
“The J&J vaccine makes up less than 5% of the more than 190 million recorded shots in arms in the United States to date,” Zients said at a news conference Tuesday.
He echoed previous comments from President Joe Biden, calling the fight agaisnt the virus “a war-time effort.”
“That’s why the president took action earlier this year, before the J&J vaccine was even authorized, to secure enough Pfizer and Moderna doses for 300 million Americans by the end of July,” he said. “So we have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day, and that puts us well on pace to meet the president’s goal of 200 million shots by his 100th day in office, and continue to reach every adult who wants to get vaccinated.”
As of Monday morning, the most recent date for which data was available, more than 120 million people nationwide have gotten at least one dose of the available COVID-19 vaccines, according to the U.S. Centers for Disease Control and Prevention. So far, 74 million Americans have been fully vaccinated.
Update 10:45 a.m. ET April 13: A CDC committee will meet Wednesday to discuss six cases of rare blood clots reported in people who got the Johnson & Johnson coronavirus vaccine.
The FDA has also launched an investigation into the cause of the clots and low platelet counts.
The CDC’s Dr. Anne Schuchat said authorities have not seen similar clots after use of the Pfizer or Moderna vaccines, and that people should continue to get vaccinated with those shots.
The agencies are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
J&J said in a statement it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it is delaying the rollout of its vaccine in Europe as a precaution.
Update 10:20 a.m. ET April 13: Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that of the six cases of rare blood clots reported in Americans who received the Johnson & Johnson coronavirus vaccine, one case has so far proved to be fatal.
The cases involved women between the ages of 18 and 48 who presented symptoms within six to 13 days of receiving the one-dose vaccine, Marks said. He added that one patient was in critical condition Tuesday.
Health officials are reviewing the available data after six people developed clots similar to cerebral venous sinus thrombosis (CVST), a rare, severe blood clot, along with a condition in which people have low blood platelet counts. Marks said such clots cannot be treated with the standard medicine, as it could prove dangerous when treating CVST.
Update 10:10 a.m. ET April 13: At a news conference Tuesday morning, acting FDA Commissioner Dr. Janet Woodcock emphasized that the recommendation to pause administration of the Johnson & Johnson vaccine came out of an “abundance of caution” due to six reports of a “rare and severe type of blood clot” forming in people who have received the single-dose vaccine.
“We’re recommending this pause while we work together to fully understand these events and also so we can get information out to health care providers and vaccine recipients,” Woodcock said.
“Right now, I’d like to stress that these events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of adverse events following vaccination very seriously.”
Update 9:45 a.m. ET April 13: Mississippi and Ohio have joined the growing list of states opting to pause administration of the Johnson & Johnson coronavirus vaccine following a recommendation from federal health officials.
Officials with the Mississippi Department of Health instructed all physicians, clinics and hospitals to stop using the vaccine until additional guidance is released by the CDC and the FDA, WHBQ-TV reported.
Ohio Gov. Mike DeWine, Ohio Department of Health Director Stephanie McCloud and Chief Medical Officer Dr. Bruce Vanderhoff released a joint statement Tuesday morning telling vaccine providers to take a “temporary pause” on administering Johnson & Johnson vaccines, according to WHIO-TV.
Update 9:20 a.m. ET April 13: Officials with the Massachusetts Department of Public Health said they were notifying all providers of coronavirus vaccinations in the state to pause their use of the Johnson & Johnson coronavirus vaccine, WFXT reported.
Update 9:10 a.m. ET April 13: Health officials in New York state said Tuesday that they will stop administering the Johnson & Johnson coronavirus vaccine “immediately” after officials with the CDC and the FDA called for the pause.
New York residents slated to get the vaccine will be offered the Pfizer vaccine instead at state-run mass vaccination sites, Department of Health Commissioner Dr. Howard Zucker said in a statement.
“As the CDC and FDA have said, any adverse events related to the Johnson & Johnson vaccine ‘appear to be extremely rare’ and, ‘People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.’”
Original report: Six cases “of a rare and severe type of blood clot” occurred in women who received the single-dose vaccine in the United States, the statement said. More than 6.8 million doses of the vaccine have been administered in the country so far, according to the agencies.
“Right now, these adverse events appear to be extremely rare,” the statement read, adding that “treatment of this specific type of blood clot is different from the treatment that might typically be administered.”
The CDC’s Advisory Committee on Immunization Practices will meet Wednesday to review the cases, the agencies said. The FDA also will review the analysis and investigate the cases.
“Until that process is complete, we are recommending this pause,” the statement read. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
The agencies will host a news conference about the decision at 10 a.m. EDT Tuesday. Listen to the news conference here.
”#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the statement read.
In response to the announcement, Johnson & Johnson released a statement saying its No. 1 priority is “the safety and well-being of the people who use our products.”
“We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards,” the statement read.
“We are aware that thromboembolic events, including those with thrombocytopenia, have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”
The company also vowed to work closely with regulators “and support the open communication of this information to health care professionals and the public,” according to the statement.
According to The Associated Press, federal distribution channels and mass vaccination sites will pause use of the vaccine. States and other providers are expected to follow the recommendation, as well, the AP reported.
The Associated Press contributed to this report.
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